Allowing ICER into Medicare Does Not Achieve Value

July 15, 2016By Donna Cryer

As the foundation of the healthcare policy landscape undergoes a tectonic shift that promises to reward “value” in care rather than “volume” of services, stakeholders of all types have cautiously applauded these changes as needed reforms. Yet, when patients see these principles applied – as is the case with a recent Medicare Part B Drug Payment Model – we can’t help but ask: “value to whom?”

Health insurers, public and private, should support the provision of care that taxpayers, employers – people – find valuable to optimizing health. However, all too often payer perspectives don’t align with those of patients, caregivers, and clinicians. The latest misalignment of payer and patient perspectives comes in the form of a Medicare proposal which would rely on cost-based recommendations from groups like the Institute for Clinical and Economic Review (ICER) to determine the “value” of care for patients. While ICER purports to be an independent, unbiased arbiter of value assessment, their analyses are intended for use by payers – often at the expense of patient access to life-saving medications.

On the other hand, the President’s recently reiterated his promise for personalized medicine in a Boston Globe editorial, stating, “Instead of trying a one-size-fits-all treatment, what if medical experts could tailor one specifically for everyone’s body?” Exactly what patients have been saying.

As a liver transplant patient, I’ve watched closely ICER has targeted treatments related to the liver three times – an area starved for new medications. Today, ICER is meeting about Primary Biliary Cholangitis (PBC), a rare autoimmune disease that primarily affects women in their childbearing years, and non-alcoholic steatohepatitis (NASH) which has no FDA-approved treatment to evaluate. ICER will hear from patients and clinical experts today, but it remains to be seen whether they listen. ICER reports were the rationale for payer denials or restrictions to HCV cures experienced by patients and physicians across the country, despite ultimately being deemed cost-effective. Hepatitis C (HCV) is a disease that kills more Americans than the next 60 infectious diseases combined and is the top driver of liver cancer and liver transplants. If a cure for any other deadly infectious disease or cancer were found, the nation would applaud the innovation, and any barriers to patient access would be deemed unconscionable.

It is unacceptable when payers, instead of patients and providers, use these reports to drive clinical decision-making based on mathematical assessments of so-called “average value” – although I’ve never met an “average” patient. It is even more frustrating to think that public programs could sidestep patient protections embedded in the Medicare law through a nationwide “demonstration project” that would allow these assessments to define treatment value.

ICER targets medications that are game changing for the quality of life and even survival of certain patients. Patients have respectfully highlighted the flaws in ICER’s methodology, scoping reports, voting questions, and stakeholder engagement process which seriously undermine any “value” articulated in their reports. Indeed, I am not surprised that ICER’s past recommendations come up short – I know firsthand they lacked patient and clinical subject matter experts throughout their process.

If Medicare Part B adopts ICER or any cost-based determination of value, it will be opening Pandora’s box to a dangerous world of rationing that has rightfully galvanized the patient community. Patients want access to the innovation brought forth by the President’s Precision Medicine Initiative so that health care is valuable to the patient, the ultimate payer.